ALIPZA 2 mg FILM-COATED TABLETS

1. What is Alipza and what is it used for

Alipza contains a substance called pitavastatin. It belongs to a group of medicines called ‘statins’. Alipza is used to correct blood fat (lipid) levels and can be taken by children from 6 years and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or stroke.

You have been prescribed Alipza because you have an imbalance of fats, and changes in your diet and lifestyle have not been enough to correct it. You should continue with a low-cholesterol diet and lifestyle changes while taking Alipza.

2. What you need to know before you take Alipza

Do not take Alipza:

• if you are allergic to pitavastatin or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding.
• if you are a woman and can become pregnant, and you are not using a reliable contraceptive method (see ‘Pregnancy and breast-feeding’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after organ transplantation.
• if you have repeated or unexplained muscle pain.

If in doubt, consult your doctor or pharmacist before taking Alipza.

Warnings and precautions

Consult your doctor or pharmacist before taking Alipza if:

• you have severe respiratory problems (severe breathing problems);
• you have ever had kidney problems;
• you have ever had liver problems. ‘Statins’ can affect the liver in some people. Your doctor will usually do blood tests (to see how your liver is working) before and during treatment with Alipza;
• you have ever had thyroid problems;
• you or a family member have a history of muscle problems;
• you have previously had muscle problems when taking other medicines to lower cholesterol (e.g. statins or fibrates);
• you drink a lot of alcohol;
• you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Alipza can cause serious muscle problems (rhabdomyolysis);
• you have or have had myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

If any of the above applies to you (or you are in doubt), consult your doctor or pharmacist before taking Alipza. Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medicines may be necessary to diagnose and treat this problem.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

Alipza should not be given to children under 6 years of age.

Before taking Alipza, adolescent girls should receive guidance and advice on contraceptives.

Other medicines and Alipza

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can interfere with others.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines called ‘fibrates’, such as gemfibrozil and fenofibrate;
• erythromycin or rifampicin, antibiotics used for infections;
• warfarin or any other medicine used to thin the blood;

• medicines for HIV called ‘protease inhibitors’ (e.g. ritonavir, lopinavir, darunavir, atazanavir) and ‘non-nucleoside reverse transcriptase inhibitors’ (e.g. efavirenz);
• niacin (vitamin B3);

If any of the above applies to you (or you are in doubt), consult your doctor or pharmacist before taking Alipza.

Taking Alipza with food and drinks

You can take Alipza with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are a woman who can become pregnant, you must use a reliable contraceptive method while taking Alipza. If you become pregnant while taking Alipza, stop taking Alipza and contact your doctor immediately.

If you are pregnant or breast-feeding, consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Alipza is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking Alipza, do not drive or use machines or tools.

Alipza contains lactose

Alipza contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Alipza

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Taking this medicine

Swallow the tablet whole with water, with or without food. You can take it at any time of the day. However, try to take the tablet at the same time every day.

How much to take

• For adults, the usual starting dose is 1 mg once a day. After a few weeks, your doctor may decide to increase the dose. The maximum dose in adults and children over 10 years is 4 mg a day.
• If you have liver problems, do not take more than 2 mg a day.

Use in children

• The maximum dose in children under 10 years is 2 mg a day.
• If necessary, the tablets can be dispersed in a glass of water just before taking; then rinse the glass with more water and drink immediately. Do not use fruit juices or milk to disperse the tablets.
• Alipza is not recommended for children under 6 years of age.

Other things you need to know while taking Alipza

• If you go to the hospital or receive treatment for another problem, tell the medical staff that you are taking Alipza.
• Your doctor may do regular blood tests to check your cholesterol levels.
• Do not stop taking Alipza without talking to your doctor first. Your cholesterol levels may increase.

If you take more Alipza than you should

If you take more Alipza than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Alipza

Do not worry, take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine can cause the following side effects:

Stop taking Alipza and see a doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Allergic reaction: some of the signs are difficulty breathing, swelling of the face, lips, tongue, or throat, problems swallowing, intense itching of the skin (with hives).

• Unexplained muscle pain or weakness, especially if you feel unwell, have a fever, or if your urine is brownish-red. In rare cases (less than 1 in 1,000), Alipza can cause unpleasant muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can cause kidney problems.

• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Liver problems that can cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (severe abdominal and back pain).

Other side effects include:

Common (affects less than 1 in 10 people)

• joint pain, muscle pain
• constipation, diarrhea, indigestion, nausea
• headache

Uncommon (affects less than 1 in 100 people)

• muscle spasms
• weakness, tiredness, or malaise
• swelling of the ankles, feet, or fingers
• stomach pain, dry mouth, vomiting, loss of appetite, taste disturbance
• pallor and weakness or shortness of breath (anemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (or other sleep disorders, including nightmares)
• increased need to urinate (urinary frequency)
• numbness and reduced sensitivity in the fingers and toes, legs, and face

Rare (affects less than 1 in 1,000 people)

• redness of the skin, rash, and itching of the skin
• vision loss
• tongue pain
• unpleasant sensation or discomfort in the stomach
• breast enlargement in males (gynecomastia)

Frequency not known (cannot be estimated from the available data)

• constant muscle weakness.

• lupus-like syndrome (with rash, joint disorders, and effects on blood cells)
• severe myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).

• Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects

• memory loss
• sexual dysfunction
• depression
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alipza

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep the blister pack in the outer carton to protect from light.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Alipza

• The active substance is pitavastatin calcium, equivalent to 1 mg, 2 mg, or 4 mg of pitavastatin.
• The other ingredients are lactose monohydrate, LS-hydroxypropylcellulose, hypromellose (E464), titanium dioxide (E171), triethyl citrate (E1505), magnesium aluminometasilicate, magnesium stearate, and anhydrous colloidal silica.

Appearance and packaging of the product

Alipza film-coated tablets are available in packs of 7, 28, 30, 90, or 100. Not all pack sizes may be marketed.

The tablets are round, white, and engraved with ‘KC’ on one side. To help identify the different strengths, they are of different sizes and engraved with ‘1’, ‘2’, or ‘4’ on the other side.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Kowa Pharmaceutical Europe GmbH.

Görreshof 151, 53347 Alfter,

Germany.

Manufacturer:

Pierre Fabre Médicament Production*,

Rue du Lycée, 45502 Gien Cedex

France

Or

Recordati Industria Chimica e Farmaceutica S.p.A.*

Via M. Civitali, 1, 20148 Milan

Italy

Local representative:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Date of last revision of this leaflet: April 2023

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/